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RecruitingNCT03499197Updated Apr 17, 2018

Heart TIMING - Heart Transplantation IMagING

An observational study in Heart Transplant Failure and Rejection and Magnetic Resonance Imaging, sponsored by Semmelweis University Heart and Vascular Center. Recruiting at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-17.

Sponsored by Semmelweis University Heart and Vascular Center · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2021, 5 years 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2018; still recruiting 8 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

The cardiac allograft rejection (CAR) and cardiac allograft vasculopathy (CAV) significantly affect the prognosis of patients after heart transplantation. The aim of the present study is to investigate and differentiate the adaptive and pathological cardiovascular changes after heart transplantation using different modalities. The investigator's main purpose is to define the role of the cardiovascular imaging methods and biomarkers in the early diagnosis of CAR and CAV.

Read the detailed description
  1. 12-lead ECG - Resting standard 12-lead digital ECG will be recorded. Extended analysis will be performed according to the latest recommendations.
  2. Holter ECG - 24 hour Holter ECG will be recorded. Extended Holter ECG analysis will be performed.
  3. Life quality questionnaire, patient history - Detailed questionnaire about personal and family history, general symptoms and life quality.
  4. Laboratory biochemical examination - Besides the regular routine laboratory parameters, several specific parameters are planned to be measured, such as cardiac biomarkers.
  5. Endomyocardial biopsy
  6. Detailed transthoracic echocardiography including strain analysis and 3D measurement
  7. Detailed cardiac magnetic resonance (CMR) examination
  8. Coronary imaging - invasive coronarography and intravascular ultrasound (IVUS) and/or optical coherence tomography (OCT)
  9. Invasive pressure measurement - Measurement of coronary flow reserve (CFR) and microcirculation resistance index (IMR)
02

Conditions studied

  • Heart Transplant Failure and Rejection
  • Magnetic Resonance Imaging
03

In context

Lead sponsor

Semmelweis University Heart and Vascular Center is the lead sponsor of 29 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients who underwent first cardiac transplantation.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • First heart transplantation

Exclusion criteria

Exclusion Criteria:

  • Cardiogenic shock on/after day 28 after heart transplantation
  • Lack of consent
  • Lack of cooperation
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Interventions

  • Diagnostic testcardiac magnetic resonance imaging

    Detailed and regular CMR examination (LGE, stress perfusion, T1, T2 mapping)

06

What researchers measure

Primary outcomes

  1. Coronary allograft vasculopathy

    Coronary allograft vasculopathy confirmed based on IVUS/OCT

    Time frame: 5 years

  2. Coronary allograft rejection

    Coronary allograft rejection confirmed based on endomyocardial biopsy/clinical parameters

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2018 (actual). Primary completion is estimated for Jan 2021, 36 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 11, 2018
First posted
Apr 17, 2018
StartActual
Jan 15, 2018
Primary completionEst.
Jan 15, 2021
CompletionEst.
Jan 15, 2026
Last update
Apr 17, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03499197
Lead sponsor
Semmelweis University Heart and Vascular Center
Collaborators
National Research, Development and Innovation Fund of Hungary, Project no. NVKP_16-1-2016-0017
Responsible party
Hajnalka Vágó MD PhD (MD PhD, Associate Professor, Semmelweis University Heart and Vascular Center) — Principal investigator
First posted
Apr 17, 2018
Start date
Jan 15, 2018
Primary completion
Jan 15, 2021 (estimated)
Completion
Jan 15, 2026 (estimated)
Last update
Apr 17, 2018

Study contacts

Hajnalka Vago, MD, PhD
Contact
vagoha@gmail.com
+3620 8258058

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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